Bigliani/Flatow® 00-4301-046-21
GUDID 00889024265103
Zimmer, Inc.
Humeral head prosthesis trial, reusable| Primary Device ID | 00889024265103 |
| NIH Device Record Key | ade0af47-17f2-4a7f-9c14-7ca60a06b605 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bigliani/Flatow® |
| Version Model Number | 4301-46-21 |
| Catalog Number | 00-4301-046-21 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com |
Device Dimensions
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024265103 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K103404
FDA Product Code
| KWT | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024265103]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2019-10-09 |
| Device Publish Date | 2016-07-14 |
On-Brand Devices [Bigliani/Flatow®]
Trademark Results [Bigliani/Flatow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIGLIANI/FLATOW 75577076 2369417 Live/Registered |
ZIMMER, INC. 1998-10-26 |
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